1. 1 The Role of Medicare National Coverage in the Regulatory Process Steve Phurrough MD, MPA Director, Coverage and Analysis Group Centers for Medicare and Medicaid Services

2. 2 “Today more than ever, we must get more for what we spend on health care. We’ve got to generate valuable innovation in medical products to reduce errors, complications, and unnecessary care while improving quality. All that’s necessary to understand how urgent this is to consider the alternative: crude forms of cost cutting, in ways that reduce the incentives for medical progress while doing nothing to make our fragmented system work better. We owe it to the patients we serve to be more clinically sophisticated than that.” Mark McClellan, September 2004

3. 3 “While I can explain the meaning of life, I don’t dare try to explain Medicare reimbursement.”

4. 4 Steps to Coverage Determination and Payment Outside of CMS: Congress determines benefit categories FDA approves drugs/devices for market Within CMS: Coverage Coding Payment

5. 5 FDA If the technology requires FDA approval, then that technology must have FDA approval for at least one indication.

6. 6 Benefit Category Determination SSA 1861: Congress determines the services that CMS covers Examples: –Hospital services –Physician services –Colorectal cancer screening

7. 7 MEDICARE NATIONAL COVERAGE PROCESS Internal Technology Assessment Draft Decision Memorandum Posted National Coverage Request Medicare Coverage Advisory Committee External Technology Assessment 6 months Reconsideration Staff Review Public Comments Final Decision Memorandum and Implementation Instructions 30 days60 days 9 months Preliminary Discussions Benefit Category Department Appeals Board

8. 8 Statutory Basis for Coverage Sec. 1862 (a)(1), Title 18, SSA “...no payment may be made...for expenses incurred for items or services... [which], except for items and services described in a succeeding subparagraph, are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.”

9. 9 Reasonable and Necessary Safe and effective (per FDA, if applicable) Adequate evidence to conclude that the item or service improves health outcomes –emphasis of outcomes experienced by patients –generalizable to the Medicare population –as good or better than current covered alternatives Future Agency action will provide greater detail on producing “adequate evidence”

10. 10 Improved Health Outcomes Evidence-based medicine

11. 11 EBM: Definition “...Evidence-based medicine de-emphasizes intuition, unsystematic clinical experience, and pathophysiologic rationale as sufficient grounds for clinical decision making and stresses the examination of evidence from clinical research.” Evidence-Based Medicine Working Group, JAMA (1992)

12. 12 EBM Good Evidence Applicable Results

13. 13 National Decisions National Coverage National Noncoverage National Coverage with restrictions –Specific populations –Specific facilities/physicians –Coverage with evidence development

14. 14 Population Restrictions Population in trial unless clear path to generalize results to Medicare population

15. 15 Facility Standards Transplant centers Lung Volume Reduction Surgery Left Ventricular Assist Devices Carotid Stents Bariatric Surgery

16. 16 Evidence Development Coverage with Appropriateness Determination R&N under 1862(a)(1)(A) but additional data needed to ensure the item or service provided in an R&N manner Coverage with Study Participation Not R&N under 1862(a)(1)(A) but R&N under 1862(a)(1)(E)

17. 17 Recent Decisions ICDs PET scans for Alzheimer Colorectal Cancer drugs Cochlear implants PET scans for oncology indications Home Oxygen

18. 18 “We will have to have more comprehensive and timely evidence on the value of new medical treatments. With this evidence, we could do a better job of helping patients find the right treatments for their needs and help health care providers make better use of quality measures and payment incentives. It would encourage the more rapid diffusion of new treatments that really are worthwhile. Together these steps will improve medical innovation, since it would be clearer to product developers that they will be rewarded when and only when their new treatments truly add value to patient care. We cannot get this valuable evidence unless more routine and extensive data collection and analysis tools are systematically built into our delivery of care.” Mark McClellan, Sept 2004

19. 19 CMS/FDA Part A&B: CMS coverage ≠ FDA approval –Labeled indications may not be covered –Unlabeled indications may be covered

20. 20 CMS/FDA Cooperation Pre-approval & pre-coverage Postmarket surveillance

21. 21 Contact Information Steve Phurrough steve.phurrough@cms.hhs.gov 410-786-2281